FAQs

Where is the IRB administrative office?
Wickes Hall 314

Who do I contact if I have questions?
IRB Manager Melissa Woodward, (989) 964-7488, mal@svsu.edu or IRB Chair Elizabeth Roe, (989) 964-4128, irbchair@svsu.edu.  

What rules must the IRB follow?
Federal guidelines "The Common Rule (45 CFR 46)" is the foundation for IRB rules.  Additional rules/laws are applied by the state of MI

What guidelines does the IRB follow?
The institutional IRBPoliciesAndProcedures (131KB)

How are people appointed to the IRB? Can we have access to vitas of IRB members?
Do all reviewers have PhDs or personal research experience?
The Vice President for Academic Affairs appoints members of the IRB. Curriculum Vitae for each member of the IRB can be obtained by asking the member for a copy; presumably, each member of the IRB will comply as a matter of professional courtesy. By design, all reviewers do not have personal research experience. The federal regulations require that at least one member of the IRB be a nonscientist. The purpose of this requirement is that each proposed project must be evaluated from many different viewpoints, not merely from the viewpoint of the scientific quality of the project.

According to federal regulations, some research is “exempt”. Does this mean I do not
need to go through the IRB? No, you must submit an RPA. “Exempt” is a classification that is used by the IRB to determine whether or not the IRB needs to maintain continued supervision of the research. Obviously, the IRB cannot determine whether or not research fits the “exempt” category if the IRB does not know about the research.

If I am a qualitative researcher, do I need to go through the IRB? Probably yes. The key is whether or not your qualitative investigation involves humans, is systematic, and is done for the purpose of developing or contributing to generalized knowledge.

 When is IRB review required?

• Any study that requires human participants and meets the definition of “Research”
• Research is defined by federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge". 
• Generalizable knowledge draws conclusions from information obtained to apply to populations outside of the study (professional association) usually through publication and or presentation
• One should refer to the IRB Decision Tree. Generally, any research in which humans will be questioned or otherwise observed needs to be submitted to the IRB. Research involving animals other than humans should be submitted to the Institutional Animal Care and Use Committee (IACUC).

What are the different types of IRB review?

• Full Board protocols
  • High level of risk to participants (above minimal risk)
  • Research is identifiable and sensitive
  • Research does not fit any of the Expedited categories
• Expedited protocols
  • Minimal risk to participants
  • Research is identifiable and sensitive and falls within one of the expedited categories (1-7)
• Exempt from full board review protocols
  • Less than minimal risk to participants
  • Research that is identifiable but not sensitive
  • Research that is sensitive but not identifiable
  • Research that is not sensitive and not identifiable
• Nonhuman Participant Research
  • Research that involves no interaction with an individual and only de-identified data.  UNCG researchers have no access to identifying information
  • Research that is designed to preserve a historic event only and there is no attempt to draw generalized conclusions from data collected

According to federal regulations, some research is “exempt”. Does this mean I do not need to go through the IRB? No, you must submit an RPA. “Exempt” is a classification that is used by the IRB to determine whether or not the IRB needs to maintain continued supervision of the research. Obviously, the IRB cannot determine whether or not research fits the “exempt” category if the IRB does not know about the research.

How long does the initial review process take?

• A full board review protocol takes approximately six weeks if  well written and the protocol is complete
• An Expedited review protocol takes approximately one month if well written and the protocol is complete
• An Exempt from further review protocol takes approximately two weeks if  well written and the protocol is complete
• A Determination of not Human Participant Research takes approximately one week if well written and the protocol is complete

What if I don’t get approval from the IRB prior to conducting my study?

• Individuals that do not acquire IRB approval prior to data collection are noncompliant and are liable for any and all negative outcomes.
• Instances of research that has not been approved by the IRB are referred to the Vice President for Academic Affairs for action; the IRB has no enforcement mechanism; the IRB is an advise-and-consent group. Ultimately, although there are many, many steps in between, an institution that does not conform to the federal regulations can be stripped of all federal funding and denied participation in all federally funded programs.

Is there such a thing as “retroactive” approval? No. All projects must be reviewed and approved prior to data collection.

When does a study require full board review?

• When research involves highly sensitive information/methodology and vulnerable populations with a lot of serious risks to participants
• When research does not fit in one of the expedited categories
• When research does not have clear benefits but does have a clear high level of risk

What happens with my protocol once I submit?

• 1^st The protocol is logged into the database
• 2^nd The protocol is initially reviewed
• 3^rd An approval is issued for (Exempt/Non Human Participant Research) or the protocol is forwarded to the IRB chair 

Is there a way to get feedback on proposals before formal submission to the IRB? Proposals can be submitted to the Chair, or any other cooperating member of the IRB, for prior review, but such review is rarely necessary. RPAs submitted to the IRB are assigned a reviewer as soon as possible.

Does the committee give feedback on proposals that were not approved? What if I don’t
agree with the feedback? It is rarely the case that a proposal will be rejected, although it has happened in the history of the SVSU IRB. Instead, the IRB Liaison works with the project’s Contact Person to ensure that the proposal will be approved. If the investigators do not agree with the Liaison’s feedback, they are free to request that another Liaison be assigned. The goal of the IRB is to be able to approve every proposed project. However, when investigators choose not to cooperate with the IRB, then the project could be rejected, in which case the investigators may not proceed with the project

How long are IRB approvals valid? The approval period of an exempt protocol is 3 years. The approval period of an nonexempt protocol is determined by the IRB but not more than one year

How will I know when its time to renew my project? Renewal reminder notices are sent out 30 and 60 days in advance to the PI named on the protocol

What happens if I miss my renewal deadline? All research activities must cease until approval is obtained

How long does the renewal process take? If all documents are sent along with the renewal the review and approval process takes approximately two weeks

If I submit a modification during my approval period does that count as a renewal of my protocol? 
No, a modification change components of the currently approved protocol not the approval period

Are there examples of successful proposals to which students and faculty could have
access? Do these examples include an array of research designs? Because RPAs are considered confidential, the IRB does not make copies of them available to the public. However, one can always request a copy of a successful RPA directly from the researcher(s) who submitted it.

I plan to conduct online research. Are there any special things I need to do? At one level, there is nothing special. Online research must be reviewed by the IRB just the same as any other research. However, there probably are issues related to online research, such as informed consent, that you may need to handle differently from “inperson” research. Therefore, it may be a good idea to become familiar with information
concerning justifications for waiving written documentation of consent (getting signatures on a consent form). The distinction between confidentiality and anonymity also comes to mind as something that may be relevant to online research (but not exclusively to online research). Visit http://www.svsu.edu/institutionalreviewboard/internetresearch/ for further information regarding online research.

When is a modification necessary? A modification is necessary whenever a PI deviates from the approved protocol

Can I make changes to my protocol and inform the IRB later? No, the IRB must approve any changes prior to implementation

Are all modification viewed the same by the IRB? There are two types of modifications minor and significant (see examples below)

Significant Changes

1. Working with kids in standardized school and wanting to add kids from a school for adjudicated youth (Alternative Schools)
2. Working with pregnant women and wanting to add pregnant minors.
3. Incorporating invasive measures to a study such as therapy that could lead to depression or rekindled psychotic disorders
4. Adding a site to conduct research that the PI has a clear conflict of interest
5. Adding procedures that include the use of Personal Health Information (PHI)
6. Adding procedures for data collection that involve student rights (FERPA)
7. Changing survey procedures from anonymous survey to collecting identifiers (this could mean a new IRB application)

Minor Changes

1. Increasing the sample size for a study
2. Changing the stimuli for an experimental study (e.g., memory lists of words to memory lists of pictures, as long as the pictures are of the same caliber or similar response)
3. Requesting additional contact information (email or fax number)
4. Changing PI of equal capabilities or adding students to a project
5. Adding sites to collect data of same caliber (another high school in the USA not a high school from overseas)

All minor changes must meet both of the following criteria:

• All added procedures involve no more than minimal risk
• All added procedures fall into categories (1)-(7) of research that could be reviewed using the expedited procedure

If my protocol was initially reviewed by the full board do all of my modifications need to go back to the full board? For each modification the IRB will make a determination if the change will require review by the full board review

Why do I have to get informed consent? Informed consent assures that prospective human participants will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate

Are there different ways that I can obtain informed consent?

• The long form (STRONGLY RECOMMENDED)
• The short form with oral presentation

What information needs to be in the informed consent form?

(1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

(2) a description of any reasonably foreseeable risks or discomforts to the participant;

(3) a description of any benefits to the participant or to others which may reasonably be expected from the research;

(4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;

(5) a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;

(6) for research involving more than minimal risk, an explanation as to whether any compensation will be made and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

(7) an explanation of whom to contact for answers to pertinent questions about the research and research participants' rights (Eric Allen , Director of Office of Research Compliance, 256-1482); and

(8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Do I always need to have a consent form signed and dated? In most cases yes the informed consent document has to be signed and dated.  The regulations allow for waiving this requirement if the subject’s signature poses more risk than the absence of the signature, such as in particularly sensitive projects for which knowledge that a person merely participated might be deemed damaging in some way, or for projects in which obtaining signatures places an undue burden upon the researcher that the would severely, negatively impact the likelihood of accomplishing the research.The IRB can determine if the research meets the criteria for waiving documentation (signed informed consent).

Is it possible to get a waiver of informed consent or elements of informed consent? In most cases some form of informed consent is required. The IRB can determine if certain elements of informed consent can be waived or the entire process of obtaining informed consent

Where can I find samples of informed consent forms? You can find a template at SVSU's IRB website under Forms and Templates. If you are conducting research similar to that conducted by another researcher, one can request copies of that researcher's consent forms directly from the researcher.

What options do I have for obtaining my training? CITI (online module)

Which CITI modules are accepted by the IRB?  
Most investigators should complete either the "Biomedical Research Investigators" or the "Social & Behavioral Research Investigators" curriculum, depending on the type of research conducted (click How to access Basic and Refresher Courses in CITI (16KB) (18kB) to learn how to access courses required for IRB review).  Investigators who are conducting FDA research should also complete "Good Clinical Practice" curriculum.  Additional curricula, such as "Students conducting no more than minimal research" and "Research with data or laboratory specimens only" might be useful for introducing students to ethical research issues, but do not qualify as sufficient training for human-subjects research undergoing IRB review. Those who wish to know more about the IRB, are contemplating serving on the IRB, or are actively serving on the IRB should complete the "IRB Members" curriculum.

‌How long is my training certificate valid?  
3 years

Does everyone on a research project need a certificate of training?  
Yes, the Principal Investigator, Faculty Advisor, and any other researchers listed on the IRB Application must complete training.

Do ALL faculty have to take the online IRB course or just those submitting to the IRB?
Any individual affiliated with SVSU who wishes to conduct human-subjects research must complete training that has been approved by the IRB. This includes anyone connected with a particular research project. However, someone who has recently completed training for one project need not complete additional training when collaborating on a different project. Faculty who do not intend to conduct human-subjects research, either individually or in collaboration with others, need not complete the training.

Is IRB-related training required before faculty can do research and, if so, where can we
get the training?
Yes, training is required. The IRB website contains URL(s) for approved on-line training. Other types of training may satisfy the requirement, but such training needs to be approved by the IRB Chair in advance.

Do course assignments that deal with human subjects need to go through the IRB?
If the project involves accessing humans and constitute a “systematic investigation … designed to develop or contribute to generalizable knowledge,” then it needs to be submitted to the IRB. Course projects that are conducted only to provide students with experience at research procedures and do not involve producing generalized knowledge probably do not need to be submitted. Refer to the IRB Decision Tree for more clarification.

How might a faculty member teaching a research-oriented capstone course manage the submission of 20-25 proposals to the IRB? Have some faculty members been successful
with this, and are there any tips that might be supplied? One suggestion is to alert the IRB Chair of the large number of incoming proposals so that the Chair can make arrangements (extra meetings, etc.) to ensure timely review of the proposals. The review process is faster when RPAs have been completed properly, so the faculty member can speed up the process by ensuring that only adequate RPAs are submitted to the IRB. Advice from other faculty members who have supervised multiple projects simultaneously should be sought as well. Having the IRB Chair, or some other IRB Member, visit the class to explain what is required in an RPA would certainly be helpful.

What is the turn-around time for a 15-week class of 20-25 students if all students submit
to the IRB? This is a concern given the IRB is scheduled to meet only once a month. Turn-around time is difficult to estimate because each project must be reviewed on its own merits and there are many conditions that affect turn-around time (complexity of the project, quality of the RPA, etc.). Many projects do not require a full meeting of the IRB (this is called Expedited Review), and turn-around time for such projects is not affected by the schedule of regular IRB meetings. However, for those projects that do require a meeting of the full IRB, the IRB Chair will make every attempt to schedule additional IRB meetings to meet demands for reviews.

Related to a research course, given that we have 15 weeks, what should one do in the event of indecision about whether it is research or inquiry? As noted elsewhere, the IRB is tasked with deciding whether or not a project involving data collection from humans falls within the purview of the IRB. Therefore, the short answer to this question is that the project should be subjected to the IRB Decision Tree and, if necessary, submitted to the IRB as soon as possible. The Decision Tree contains questions that enable the IRB to make a very fast determination of projects in this regard, so the length of the semester should not pose a problem.

Do members of the IRB come to talk with classes to provide an overview and give insight into expectations? There currently exists no organized program for classroom visits. However, the IRB Chair has agreed to meet with any class within normal scheduling reservations. Other IRB members may also be so willing, and interested individuals are encouraged to contact IRB members concerning such visits.

If a faculty member does not know the answer to questions about the IRB, should the faculty member contact a member of the IRB or should the student do that? Ideally, the faculty member should contact the IRB; that way, the faculty member will know the answer for the next student who asks that question. Practically, however, it doesn’t matter who contacts the IRB, so long as the answer is relayed to all members of the research team.

Can children consent to participate in research? No, children give their assent to participate in research

How old does a child have to be in order to give assent? 5 years old

Are the elements of informed consent the same as those for assent? For the most part yes but the age and cognitive abilities of the kid may merit a wavier of some of the elements

Do I have to obtain permission from the child’s parent before working the child? Yes, parental permission should be obtained prior to the child assent

Do both parents have to sign the informed consent form? Only when the research is of high risk and/or there is not direct benefit to the child

Is it possible to get a waiver of child assent? Yes, but the PI should provide adequate justification to the IRB

Is it possible to get a waiver of parental permission? Yes, but the PI should provide adequate justification to the IRB

In research involving minors, is ‘assent’ always required from the children? The presumptive answer is “yes,” but each project is different (and each project is reviewed independent of other projects). Obviously, very young children are not in apposition to provide assent. A justified request to waive ‘assent’ can be included in the RPA.

Do I have to have an interpreter if I plan to work with non-English speaking people? No, however it is required that you have adequate plans to communicate with non-English speaking populations

Can the IRB waive certain requirements for conducting research with illiterate or deaf populations Yes, however the PI must provide a plan to ensure that the participants understand what is going on in the research project

If there are language barriers what information do I need to submit to the IRB? Typically all research related documents must be translated into the appropriate language. A plan to communicate information as appropriate to the population.

If I conduct research in the school system do I need approval from the district or just the school in which I plan to conduct the research? All school systems don’t follow the same rules regarding conducting research in their school and the PI should discuss the policy with the school.  Some school systems require an independent review of the research by a research review committee similar to an IRB.  While others only need the principal to review and approve the research.

If both the school system and SVSU IRB need to review the protocol, who do I submit to first? This decision is up to the investigator, however SVSU recommends the PI submit the protocol to either SVSU or the school system for review first, but not simultaneously.

Do individuals that are not currently employed or enrolled at SVSU need IRB approval before conducting the study? Yes, if the project is conducted on SVSU’s campus or through SVSU facilities.

If I am conducting research somewhere else, do I still need to submit the project to SVSU’s IRB? Yes. The purview of the IRB extends to any research conducted by anyone affiliated with SVSU. The only time you need not submit an “elsewhere” project is when your participation includes absolutely no connection with SVSU (no SVSU affiliation in the publication, presentation, or publicity release, no submission to fulfill any job requirements at SVSU, etc.)

If I am leaving the university and I have an open protocol, what should I do? The PI will need to complete a IRB Renewal/Close-out Form (116KB) and submit it to the IRB. If leaving the university to work or attend another institution, then the PI/Student will need to seek approval for that study at the new institution since SVSU will no longer be responsible for the protocol 

What should a PI do if a participant is physically injured, suffers personal loss, or psychologically traumatized when participating in an approved research study? The PI is responsible for reporting any unexpected project outcomes or events to the IRB. See the Adverse Event Tree for guidance on how to report an event.

Does a pilot study always have to go through IRB approval?

No, a pilot study doesn’t always need to go to the IRB for approval, however:

• There can be no mention of SVSU IRB in the consent forms.
• There can be no language that indicates that there was IRB approval or that the IRB condoned the study.
• The study results cannot be presented as research data.

How long should records be kept for IRB?
Research records are confidential records and they are university property. Records must be stored safely in your university office or your department or another approved location at the university. Records to be kept include approved IRB documents, as well as case-report forms, tapes or transcripts, and all other data-collection instruments and source documents. Principal Investigators are responsible for maintaining records that mirror IRB Records.

• HHS regulations, records must be kept for 3 years after completion of all research activities;
• General Laws guiding contract and tort claim require records be retained for 7 years;
• FDA has specified recordkeeping and record retention requirements; generally, FDA regulated research records must be kept for 2 years after a marketing application is approved;
  o For drugs where no application is filed or the application is not approved, the retention period is two years after the investigation is discontinued and FDA is notified.
  o Contractual obligations may require records to be maintained per the agreement with the trial sponsor.
• HIPAA requires records involving the generation, disclosure, and/or use of Protected Health Information (PHI) to be retained for up to 6 years after the last subject has completed study activity;
• Records pertaining to in vitro fertilization studies or research involving pregnant women must be retained 25 years after study closure,
• If records involving minors, it must be kept until seven (7) years after the minors reaches the age of 18 years (Michigan Adult = 18 years of age);
• If retention requirements specified in funding agency regulations are longer, the agency requirements will apply;
• In addition, at the discretion of the investigator, some data may be retained longer for use in subsequent projects; and
• All records must be accessible for inspection and copying by authorized representatives of the IRB, regulatory agencies and sponsor.

What Records should Researchers Maintain?
Researchers should maintain a file of all documents relevant to the IRB review of the research
project. The principal investigator's records should be a mirror image of the IRB's records,
meaning that all documents submitted by the researcher to the IRB and all correspondence
between the IRB and the researcher should be kept on file by the researcher. Most of this recordkeeping
can be accomplished through IRBNet. Be sure to use IRBNet for all email
communication with the research team or IRB members and staff.

Documents researchers should have on file (in IRBNet or elsewhere) include but are not limited
to:
• RPA submitted to the IRB, including consent and/or assent form(s);
• IRB’s response or request for additional information or revisions;
• Responses to the IRB’s requests for additional information or revisions;
• Notice of final approval;
• Correspondence between the investigator and the IRB;
• Continuing Review forms and attachments (if applicable);
• Annual Compliance Review forms or copies of any inspection or audit reports from
internal or external entities;
• Renewal of Approval, where applicable;
• Amendment forms and attachments (if applicable);
• Amendment approval (if applicable);
• Original letters of collaboration from other institutions; and
• All approved research study materials, including IRB validated copies, if applicable (e.g.,
consent forms, recruitment materials, data collection instruments or forms, etc.)